SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY
FDA 510(k) clearance K050161 · decided 2005-02-03
Clearance details
- K-number
- K050161
- Device name
- SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY
- Applicant
- Conmed Electrosurgery
- Decision
- Substantially Equivalent
- Date received
- 2005-01-25
- Decision date
- 2005-02-03
- Days to decision
- 9 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Centennial, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.